Lab & Testing Services
Please contact our Client Care for the most up-to-date information on our testing services and for assistance with submitting a sample via EagleTrax. We look forward to serving you.
|ScanRDI® Sterility Test||2 business days||$299|
|ScanRDI Method Suitability Test (required on file)||7 business days||$1,750|
|BacT/Alert Sterility Test||8 – 10 business days||Call for Pricing|
|BacT/Alert Sterility Test Method Suitability (required on file)||8 – 10 business days||$1,000|
|USP <71> Sterility Test||14-18 business days||$125|
|USP <71> Sterility (Daily Read)||14-18 business days||$299|
|USP <71> Sterility (Direct Inoculation)||14-18 business days||$275|
|USP <71> Method Suitability Test (required on file)||7 business days||$400|
|USP <85> Bacterial Endotoxin Test (Turbidimetric)||2 business days||$99|
|USP <85> Bacterial Endotoxin Method Validation||7 business days||$450|
USP <85> Endotoxin Oven Validation
Minimum of 1 control must be provided.
|5 business days||$99/vial|
|USP <51> Anti-Microbial Effectiveness (AME) Test||35 days||$1,000|
|USP <51> Method Suitability Test (required on file)||14 days||$1,000|
|USP <60> Burkholderia Cepacia Complex||5 business days||$175|
|USP <60> Burkholderia Cepacia Complex Method Suitability (required on file)||7 business days||$750|
|USP <61> Microbial Enumeration Test||7 business days||$225|
|USP <61> Method Suitability Test (required on file)||7 business days||$799|
|USP <62> Objectionable Organisms||7 business days||$125/organism|
|USP <62> Method Suitability Test (required on file)||7 business days||$250/organism|
|USP <788> or USP <789> Particulate Count Test||5 business days||$199|
|USP <790> Visual Particulate||3 business days||$99|
|USP <1207> Container Closure Integrity Test (Utilizing the “Pressure Decay” Method)||5 business days||$550|
|USP <1207> Container Closure Integrity Test (Utilizing the “Dye Ingress” Method)||5 business days||Call for Pricing|
|USP <1231> Water for Pharmaceutical Purposes||4 business days||$195|
|USP <55> Biological Indicator (Spore Count)||10 business days||$350|
|Biological Indicator (Spore Strips, Ampoules, Dry Ampoules)||10 business days||$75/unit|
|Growth Promotion||10 business days||$275|
|Incubation||10 business days||$15|
|Media Fill||18 business days||$50 + $1.50/vial|
|Microbial Identification||10 business days||$175/CFU|
|Plate Enumeration||10 business days||$35|
Delays in analysis and/or additional costs may occur if the formula worksheet is not submitted, or if Eagle does not have current developed protocols for the active ingredient(s) present in the sample.
Uses the advanced HPLC/UHPLC and Spectrographic instrumentation. Protocols have been developed based on USP <621> and <851> methodology.
Potency – Solutions (aqueous-based)
Potency – Non-solution (capsules, gels, suspensions, creams, animal treats, powder aliquots, suppositories, troche, tablets, etc.)
|1-3 Actives||4 business days|
|4+ Actives||7 business days|
|Solid dosage forms: 1-3 Actives||5 business days|
|Solid dosage forms: 4+ Actives||7 business days|
|HCG||7 business days||$1,000|
|USP <281> Residue on Ignition||5 business days||$350|
|USP <643> Total Organic Carbon||10 business days||$200|
|USP <645> Water Conductivity||10 business days||$100|
|USP <731> Loss on Drying||5 business days||$200|
|USP <741> Melting Range||5 business days||$225|
|USP <781> Optical Rotation||5 business days||$285|
|USP<785> Osmolality & Osmolarity||10 business days||$250|
|USP <800> Environmental Swab Testing||5 business days||$225|
|USP <905> Uniformity of Dosage||5 business days||$725|
|USP <921> Water Content Determination||5 business days||$145|
|Appearance||5 business days||$35|
|Identification||5 business days||$299|
|pH||2 business days||$35|
|Raw Material Assay||5 business days||$525|
|Raw Material ID||5 business days||$299|
|Method Verification & Validation||4 – 6 weeks||$5,500 1st active, $3,500 each additional active|
|New Method Development||4 – 6 weeks||$7,750 1st active, $5,500 each additional active|
|Stability Studies||TBD||Call for Quote|
|USP Monograph Testing||TBD||Call for Quote|
ADDITIONAL TESTING SERVICES
We offer additional testing services not listed on this document. Call the Eagle Client Care Team at 832.295.1276 for more information.
*Testing begins 1 business day after sample is received.
*RUSH Service available for double the regular test price.
*SUPER RUSH Service available for triple the regular test price. Call for details.
Please note: A $50 cancellation fee will be assessed if cancellation is requested after samples have arrived at our facility. If testing has been initiated, the full price of the test will be charged.
All pricing is in USD and subject to change at any time.
View Minimum Sample Requirements (PDF)
USP <51> Antimicrobial Effectiveness:
Sterile articles packaged in multi-dose containers must be free of microorganisms throughout their entire shelf-life. Due to the potential for the introduction of microorganisms through the repeated withdrawal of individual doses, sterile products that are packaged in mutli-dose containers should contain an antimicrobial preservative. However, the concentration of an added antimicrobial preservative can be kept to a minimum if the ingredients of the compounded formulation possess an intrinsic antimicrobial activity. Antimicrobial effectiveness, whether inherent in the product or as a result of an antimicrobial preservative, must be demonstrated through USP <51> antimicrobial effectiveness testing.
USP <61> Microbial Enumeration Test:
As the presence of microorganisms in nonsterile preparations has the potential to reduce and/or inactivate therapeutic activity and adversely affect the health of patients, compounders are required to ensure that nonsterile preparations have a low bioburden that complies with established specifications for microbiological quality as outlined in USP <61>. USP <61> Microbial Enumeration tests provide a quantitative evaluation of a product’s microbial content to demonstrate compliance with established specifications.
USP <62> Tests for Specific Microorganisms:
Table 1 in USP <1111> sets acceptance criteria for the presence of certain microorganisms in a nonsterile preparation based on its route of administration. The presence of these objectionable pathogens and microorganisms cannot exceed the acceptance criteria outlined in Table 1. USP <62> testing is designed to demonstrate compliance with these requirements by quantifying the presence of specified microorganisms.
USP <71> Sterility Testing:
USP <71> outlines the compendial requirements for sterility testing that must be followed in order to be able to claim that the results of the test provide evidence that the product is sterile.
USP <71> Method Suitability Testing:
USP <71> Method Suitability Testing (MST) must be performed prior to being able to claim that the results of a USP <71> sterility test provide evidence of a preparation’s sterility. Method Suitability Testing only needs to be completed once for each compounded formulation, and consists of two parts: i) a suitability test that confirms that the growth media used for sterility testing supports the growth of certain microorganisms and ii) a validation test that demonstrates that no components of the compounded preparation inhibit microbial growth.
USP <85> Bacterial Endotoxin Testing:
As bacterial endotoxins can pose health and safety hazards to patients, USP <85> requires bacterial endotoxin testing to detect and quantify the presence of endotoxins from Gram-negative bacteria in sterile compounds. To assure patient safety, the quantity of bacterial endotoxins may not exceed threshold limits defined in USP <85>. For each bacterial endotoxin test, inhibition validation testing is performed. This testing confirms that there are no components of the formulation that will interfere with the bacterial endotoxin test and that the testing used is sensitive enough to provide meaningful, accurate data.
USP <788> Particulate Count:
Solutions must be essentially free from observable particulate matter. Due to the small amount of material and the heterogenous composition that particulate matter represents, it cannot be quantitated by chemical analysis alone.
USP <1207> Container-Closure Integrity Testing:
USP <1207> container-closure integrity testing demosntrates the ability of the container-closure system to maintain the integrity of its microbial barrier throughout the entire shelf-life of a product. Eagle utilizes a pressure decay to test container-closure integrity, which is one of the deterministic methods recommended by USP <1207>. As sterility is an event-related occurrence, container-closure integrity testing is performed to support the claim that the sterile containers in which the preparation is packaged are capable of maintaing the sterility of the product throughout its shelf life.
USP <197> Spectroscopic Identification Tests:
Identification by IR USP <197>: This test provides conclusive evidence of the identity of a substance using infrared absorption spectrums compared to a USP reference standard. Conformance with both IR absorption and UV absorption test specifications, as called for in a large proportion of compendial monographs, leaves little doubt, if any, regarding the identity of the specimen under examination.
Identification by UV USP <197>: This test provides the identity of a substance using ultraviolet absorption spectrums compared to a USP reference standard. Conformance with both IR absorption and UV absorption test specifications, as called for in a large proportion of compendial monographs, leaves little doubt, if any, regarding the identity of the specimen under examination.
USP <643> Total Organic Carbon:
Total Organic Carbon (TOC) is an indirect measure of organic molecules present in pharmaceutical waters measured as carbon. Organic molecules are introduced into the water from the source water, purification and distribution system materials, biofilm growing in the system, and the packaging of sterile and nonsterile waters. TOC can also be used as a process control attribute to monitor the performance of unit operations comprising the purification and distribution system.
USP <621> Chromatography:
USP <621> Chromatographic separation techniques are multistage separation methods in which the components of a sample are distributed between two phases, of which one is stationary and the other is mobile. The analytical chromatography methods Eagle utilizes are designed to determine the concentration of the active ingredient(s) in a compounded preparation. Testing protocols are developed based on guidelines delineated in USP <621> Chromatography and are validated according to USP <1225> Validation of Compendial Procedures and ICH Guidelines. The customer is notified immediately of any sample that does not test within acceptable limits.